Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters.

• Trial with medicinal product

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion criteria:

• Patients with 25-OH vitamin D insufficiency

• Elevated alanine aminotransferase level

• Diagnosis of definite or possible steatohepatitis (NASH)

Exclusion criteria:

• Cirrhosis, present liver disease other than NASH

• Serious diseases limiting life expectancy,

• Breast-feeding or pregnant women

• Unhealthy alcohol consumption

• Drug abuse or substitution therapy

• Use of vitamin preparations within the previous 6 months and during the study

• Weight loss >5% within 12 months before study entry

• Newly diagnosed Diabetes mellitus requiring medical treatment within 12 months before study entry

• Use of anti-obesity drugs

• Previous or current hypercalcemia

• Chronic renal disease